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A randomized, placebo-controlled trial to evaluate the safety and efficacy of Debio 4126 in patients with acromegaly previously treated with somatostatin analogs
EU CTIS ID: 2024-516616-24-00
What this study is testing
To assess the maintenance of Insulin-like growth factor 1 (IGF-1) ≤1x Upper limit of normal (ULN) in the double-blind period (Period 1) with Debio 4126 (Arm A) compared to placebo (Arm B) at W36
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥18 years of age
- Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
- IGF-1 at screening ≤1x ULN
- Acromegaly diagnosis, defined as per protocol
- Adequate bone marrow, hepatic and renal function
- To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at W34, or up to W48 when treated with rescue medication
You likely can't join if
- Compression of optic chiasm causing visual defects
- Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
- Other protocol-defined criteria apply
- Symptomatic cholelithiasis or bile duct dilatation
- Planned cholecystectomy during the trial duration
- Acute or chronic pancreatitis
See the full eligibility criteria
- Patients ≥18 years of age
- Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
- IGF-1 at screening ≤1x ULN
- Acromegaly diagnosis, defined as per protocol
- Adequate bone marrow, hepatic and renal function
- To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at W34, or up to W48 when treated with rescue medication
- Other protocol-defined criteria apply
- Compression of optic chiasm causing visual defects
- Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
- Other protocol-defined criteria apply
- Symptomatic cholelithiasis or bile duct dilatation
- Planned cholecystectomy during the trial duration
- Acute or chronic pancreatitis
- Pituitary radiotherapy
- Uncontrolled hypothyroidism
- Uncontrolled diabetes
- Pituitary surgery within 6 months before screening or planned on trial
- Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamin agonists within 3 months prior to screening
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United Kingdom
- Brazil
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United Kingdom; Brazil; Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.